General information, not legal or regulatory advice. Confirm current INVIMA holder, import, and post-market rules with qualified advisers. We do not invent rates; bioaccess® pricing is the two-part model on the rate card. No unpublished client. Always bioaccess®.
If you searched Colombia INVIMA registration holder IOR, INVIMA titular importer of record, CCAA holder Colombia medical device, you were looking for who holds the Latin American sanitary registration and who can legally import the device. Named market-access competitors on this cluster only: Emergo, Pure Global, Freyr, MedEnvoy, Qserve. We do not invent extra holder brands. Accel already sits on the LATAM Registration Holder and IOR hub; this cluster does not add a ninth Accel page. No PHI.
This is the Colombia holder page. It is market access. It is not a new first-in-human CTA. bioaccess® runs first-in-human studies in Colombia now, and Colombia’s regulatory framework is changing for the better. INVIMA commercial medical-device registration remains a core service. Use INVIMA medical device registration checklist for the controlled vs uncontrolled / foreign-holder / CCAA importer checklist. Colombia pricing: two-part pricing: a one-time registration fee per country by device class, then a lower annual holder fee from year 2 (published for Mexico, Colombia, Brazil, Peru and Argentina on the rate card).
This page expands LATAM Registration Holder and IOR. We do not republish that hub. distinct page. Distinct title. Same product: already FDA-cleared (510(k)/PMA) or CE-marked devices, held by bioaccess® as registration holder and importer of record (in Colombia through its own Colombian entity; elsewhere with its local partner). bioaccess® is a DBA of IMH ASSETS CORP. Julio G. Martinez-Clark, Co-Founder and CEO.
The card (do not invent another one)
bioaccess® pricing is two-part: a one-time registration fee per country (by device class), then a lower annual holder fee from year 2. One-time registration fee per country by class (Class I/II, IIa/IIb, III/IV): Mexico $5,000 / $8,000 / $13,250; Colombia $4,000 / $6,250 / $9,000; Brazil $6,750 / $11,500 / $22,250; Peru $4,250 / $6,500 / $10,500; Argentina $4,500 / $6,500 / $12,000. Annual holder fee from year 2: Mexico $4,500; Colombia $3,900 (our own Colombian entity holds the registration); Brazil $6,000 (Class I/II) or $7,500 (Class III/IV); Peru $4,200; Argentina $4,200. USD, excluding VAT and local taxes. Chile is quoted case by case. Prices are valid for agreements signed by 31 March 2027; this is information only, not an offer. Full table on the rate card.
What the holder does: in-country titular / RH / IOR / legal representation; post-approval modifications; agency liaison; tecnovigilancia as holder. Brazil BGMP manufacturing-site audit and INMETRO / ANATEL / telecom-EMC homologation are separate lines. Import shipments are quoted separately, per shipment (no charge if there is no import). Full terms in the proposal.
Holder is not IOR is not EU AR is not FDA US agent
Every LATAM regulator ties a live sanitary registration to an in-country legal entity. That is not a U.S. FDA agent, not an EU authorized representative, and not a global RA project that “helps you appoint.” Registration holder / titular / detentor / BRH / MRH is named on the certificate, owns the registro, runs post-market tecnovigilancia, and can typically authorize or add importers (country rules vary). Importer of record is the entity on the customs entry. In Argentina the holder is the sole importer of record; Peru requires imports through a licensed droguería. A consultancy that helps you appoint a holder is not the holder. A holder that authorizes a distributor to import is often not the customs IOR. Ask which legal entity is on the certificate and which entity is on the import entry. See importer of record for clinical trial devices for the investigational-import workstream — that is a trial object, not this commercial holder SKU.
What INVIMA holder actually is
INVIMA names a Colombian legal entity on the sanitary registration. Foreign manufacturers appoint that titular. CCAA importer rules sit next to the holder, not instead of it. See the live checklist. We will not invent an INVIMA tariff beyond the locked card. MedEnvoy, Pure Global, Freyr, Emergo, and Qserve may appear in the same search; none of them is this page. Named competitors stay on their own pages.
Do not mix trial IOR into commercial holder
Investigational-device import for a protocol is importer of record for clinical trial devices. Commercial IOR for an already-cleared device is this SKU. Avantec / Watershed public FIH copy that names Colombia is historic execution, not a reason to book a new INVIMA FIH from this page. Site pages stay off. Nanochon HOLD. Magical BTK off.
What bioaccess® still owns after you have a holder quote from somewhere else
- Registration holder / IOR across the public LATAM footprint named on market-access and the hub — not a brochure that tells you to go hire a local lawyer.
- The registration is never leverage against the manufacturer. Hub language: dedicated local entities for the manufacturer’s benefit, with defined transfer provisions in the agreement.
- Certified/sworn pages where the country requires them. Check who produces them before you compare quotes.
- Tecnovigilancia as holder after the certificate is live. A one-time filing shop is not that.
- Clinical-to-market is a different stack. FIH ops are ISO 14155. This SKU is already-cleared devices.
Colombia: first-in-human studies and market access
Public line: INVIMA commercial medical-device registration remains a core bioaccess® service. bioaccess® runs first-in-human studies in Colombia now, and Colombia’s regulatory framework is changing for the better. Country 2 on this cluster can be Panama, Chile, Brazil, Mexico, El Salvador or Colombia, where bioaccess® runs first-in-human studies now. Ethics timing in Panama and Colombia follows each committee’s meeting schedule, and the Panama country page still publishes per-patient $12K–$22K vs. $15K–$25K. Always bioaccess®. The founder podcast is Global Trial Accelerators™.
An INVIMA holder / IOR page is registro, CCAA importer rules, and tecnovigilancia — not a new FIH CTA.
Frequently asked questions
Is this the same as the LATAM Registration Holder and IOR hub?
No. The hub is the eight-firm table and the SKU. This page is INVIMA titular / IOR (registro — not new FIH). distinct page. We did not republish 95739.
Do you underwrite clinical-trial liability on this page?
No. Holder / IOR is not a carrier. Insurance pages are a different cluster. We do not name HDI as a partner.
Can I use this holder service for a first-in-human investigational device?
No. The public card is for already FDA-cleared or CE-marked devices. Investigational import is importer of record for clinical trial devices. bioaccess® runs first-in-human studies in Colombia now.
Next step
If the search that brought you here was Colombia INVIMA registration holder / IOR, start on the holder line: contact bioaccess® or market-access. Hub: LATAM Registration Holder and IOR. Mexico sibling: COFEPRIS holder / IOR.
Julio G. Martinez-Clark, CEO · bioaccess®